Testing the Addition of an Anti-cancer Drug, Ipatasertib, to the Usual Immunotherapy Treatment (Pembrolizumab) in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

July 26, 2022

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2027

Conditions
Head and Neck Squamous Cell CarcinomaMetastatic Head and Neck Squamous Cell CarcinomaMetastatic Hypopharyngeal Squamous Cell CarcinomaMetastatic Laryngeal Squamous Cell CarcinomaMetastatic Oral Cavity Squamous Cell CarcinomaMetastatic Oropharyngeal Squamous Cell CarcinomaRecurrent Head and Neck Squamous Cell CarcinomaRecurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Oral Cavity Squamous Cell CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaStage IV Hypopharyngeal Carcinoma AJCC v8Stage IV Laryngeal Cancer AJCC v8Stage IV Lip and Oral Cavity Cancer AJCC v8Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Interventions
PROCEDURE

Biopsy Procedure

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Ipatasertib

Given PO

BIOLOGICAL

Pembrolizumab

Given IV

Trial Locations (20)

10016

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York

10065

NYP/Weill Cornell Medical Center, New York

10461

Montefiore Medical Center-Einstein Campus, The Bronx

10467

Montefiore Medical Center - Moses Campus, The Bronx

11501

NYU Langone Hospital - Long Island, Mineola

20007

MedStar Georgetown University Hospital, Washington D.C.

40536

University of Kentucky/Markey Cancer Center, Lexington

53718

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center, Madison

53792

University of Wisconsin Carbone Cancer Center - University Hospital, Madison

60611

Northwestern University, Chicago

90020

Keck Medicine of USC Koreatown, Los Angeles

90033

Los Angeles General Medical Center, Los Angeles

USC / Norris Comprehensive Cancer Center, Los Angeles

91010

City of Hope Comprehensive Cancer Center, Duarte

92618

City of Hope at Irvine Lennar, Irvine

92663

USC Norris Oncology/Hematology-Newport Beach, Newport Beach

93534

City of Hope Antelope Valley, Lancaster

94304

Stanford Cancer Institute Palo Alto, Palo Alto

95817

University of California Davis Comprehensive Cancer Center, Sacramento

77555-0565

University of Texas Medical Branch, Galveston

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH